Melanoma Clinical Trial

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria:

Participants must not have ocular melanoma.
Participants must not have a history of myocarditis, regardless of etiology.
Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

814

Study ID:

NCT05625399

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 121 Locations for this study

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Dignity Health - St. Josephs Hospital and Medical Center
Phoenix Arizona, 85013, United States More Info
Miguel Gonzalez Velez, Site 0125
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The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Inderjit Mehmi, Site 0098
Contact
310-231-2153
UC Irvine Health
Orange California, 92868, United States More Info
Warren Chow, Site 0093
Contact
714-456-3905
Stanford Univ Med School Dept of Dermatology
Stanford California, 94305, United States More Info
Sunil Reddy, Site 0123
Contact
650-743-4516
The Melanoma and Skin Cancer Institute
Englewood Colorado, 80113, United States More Info
Ryan Weight, Site 0113
Contact
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States More Info
Roxana Dronca, Site 0114
Contact
507-284-2511
Ft. Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States
Greenebaum Cancer Center University of Maryland
Baltimore Maryland, 21201, United States More Info
Petr Hausner, Site 0146
Contact
410-328-6896
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Svetomir Markovic, Site 0071
Contact
507-284-2511
Oncology Hematology West P.C. dba Nebraska Cancer Specialist
Omaha Nebraska, 68130, United States More Info
Ralph Hauke, Site 0013
Contact
402-334-4773
Rutgers CINJ
New Brunswick New Jersey, 08901, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Brian Gastman, Site 0169
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216-444-2501
St. Lukes University Health Network
Easton Pennsylvania, 18045, United States More Info
Melissa Wilson, Site 0139
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212-731-6160
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Rino Seedor, Site 0124
Contact
215-955-9980
Intermountain Medical Center Campus Location
Murray Utah, 84107, United States More Info
David Gill, Site 0122
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Inova Health Care Services
Fairfax Virginia, 22031, United States More Info
Sekwon Jang, Site 0115
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202-615-8535
Local Institution - 0042
Caba Buenos Aires, 1125, Argentina
Local Institution - 0133
Ciudad Autonoma de Buenos Aires Buenos Aires, 1426, Argentina More Info
Site 0133
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Local Institution - 0145
Caba Ciudad Autonoma De Buenos Aires, 1430, Argentina More Info
Site 0145
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Local Institution - 0160
Rosario Santa Fe, 2000, Argentina More Info
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Local Institution - 0067
Buenos Aires , C1121, Argentina More Info
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Local Institution - 0050
Coffs Harbour New South Wales, 2450, Australia More Info
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Orange New South Wales, 2800, Australia More Info
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Port Macquarie New South Wales, 2444, Australia More Info
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Local Institution - 0118
Wagga Wagga New South Wales, 2650, Australia More Info
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Local Institution - 0033
Westmead New South Wales, 2145, Australia More Info
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Wollstonecraft New South Wales, 2065, Australia More Info
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Local Institution - 0090
Birtinya Queensland, 4575, Australia More Info
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Local Institution - 0008
Bendigo Victoria, 3550, Australia More Info
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Box Hill Victoria, 3128, Australia More Info
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Heidelberg Victoria, 3084, Australia More Info
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Local Institution - 0030
Prahran Victoria, 3004, Australia More Info
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Local Institution - 0109
Traralgon West Victoria, 3844, Australia More Info
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Local Institution - 0106
Nedlands Western Australia, 6009, Australia More Info
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Local Institution - 0161
Nedlands Western Australia, 6009, Australia More Info
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Local Institution - 0168
St. Poelten Lower Austria, 3100, Austria More Info
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Local Institution - 0027
Graz , 8036, Austria More Info
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Local Institution - 0078
Charleroi Hainaut, 6000, Belgium More Info
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Local Institution - 0072
Brussels , 1200, Belgium More Info
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Local Institution - 0036
Jette , 1090, Belgium
Local Institution - 0147
Curitiba Parana, 80520, Brazil
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Ijui Rio Grande Do Sul, 98700, Brazil More Info
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Local Institution - 0132
Florianopolis Santa Catarina, 88034, Brazil
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Sao Jose do Rio Preto Sao Paulo, 15090, Brazil More Info
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Local Institution - 0159
Blumenau SC, 89010, Brazil More Info
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Local Institution - 0130
Sao Paulo , 01321, Brazil More Info
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Local Institution - 0141
Calgary Alberta, T2N 4, Canada More Info
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Local Institution - 0121
Hamilton Ontario, L8V 5, Canada More Info
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Local Institution - 0103
Quebec , G1J 1, Canada More Info
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Local Institution - 0143
Temuco Araucania, 48008, Chile More Info
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Local Institution - 0140
Recoleta Metropolitana, 83804, Chile More Info
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Santiago Metropolitana, 01010, Chile More Info
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Santiago Metropolitana, 75009, Chile More Info
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Local Institution - 0074
Santiago Metropolitana, 81505, Chile More Info
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Local Institution - 0142
Vitacura Metropolitana, JC5G , Chile
Local Institution - 0119
Santiago de Chile Providencia, 75006, Chile More Info
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Local Institution - 0028
Vina Del Mar Valparaiso, 25205, Chile More Info
Site 0028
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Local Institution - 0152
Bogota , 11151, Colombia
Local Institution - 0149
Medellin , 50030, Colombia
Local Institution - 0150
Valledupar , 20000, Colombia
Local Institution - 0164
Helsinki , 00029, Finland More Info
Site 0164
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Local Institution - 0167
Tampere , 33521, Finland More Info
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Local Institution - 0162
Turku , 20521, Finland More Info
Site 0162
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Local Institution - 0108
Toulouse Haute Garonne, 31059, France More Info
Site 0108
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Local Institution - 0034
Paris Ile De France, 75475, France More Info
Site 0034
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Local Institution - 0127
Chambray-les-Tours Indre-Et-Loire, 37044, France More Info
Site 0127
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Local Institution - 0111
Lille Nord, 59000, France More Info
Site 0111
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Local Institution - 0061
Villejuif Cedex Val-De-Marne, 94805, France More Info
Site 0061
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Local Institution - 0007
Amiens , 80054, France More Info
Site 0007
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Local Institution - 0128
Bayonne , 64100, France More Info
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Local Institution - 0129
Clermont Ferrand , 63003, France More Info
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Local Institution - 0046
Dijon , 21000, France More Info
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Local Institution - 0052
Pierre-Benite , 69310, France More Info
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Local Institution - 0101
Heidelberg Baden-Württemberg, 69120, Germany More Info
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Local Institution - 0079
Ulm Baden-Württemberg, 89081, Germany More Info
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Local Institution - 0011
Regensburg Bayern, 93042, Germany More Info
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Local Institution - 0038
Buxtehude Niedersachsen, 21614, Germany More Info
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Local Institution - 0137
Ludwigshafen A. Rhein Rheinland-Pfalz, 67063, Germany More Info
Site 0137
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Local Institution - 0003
Luebeck Schleswig-Holstein, 23538, Germany More Info
Site 0003
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Local Institution - 0060
Berlin , 10117, Germany More Info
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Local Institution - 0136
Dortmund , 44137, Germany More Info
Site 0136
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Local Institution - 0166
Frankfurt , 60590, Germany More Info
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Local Institution - 0135
Goettingen , 37075, Germany More Info
Site 0135
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Local Institution - 0138
Hamburg , 20251, Germany More Info
Site 0138
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Local Institution - 0148
Koeln , 50937, Germany
Local Institution - 0165
Marburg , 35043, Germany More Info
Site 0165
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Local Institution - 0081
Tuebingen , 72076, Germany More Info
Site 0081
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Local Institution - 0026
Afula North, 18341, Israel More Info
Site 0026
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Local Institution - 0173
Tel Aviv-Yafo Tel Aviv, 64239, Israel More Info
Site 0173
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Local Institution - 0054
Jerusalem , 91120, Israel More Info
Site 0054
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Local Institution - 0170
Milano Milan, 20133, Italy More Info
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Local Institution - 0051
Bari , 70124, Italy More Info
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Local Institution - 0077
Genova , 16132, Italy More Info
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Local Institution - 0084
Napoli , 80131, Italy More Info
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Local Institution - 0104
Monterrey Nuevo Leon, 64460, Mexico More Info
Site 0104
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Local Institution - 0174
Cancun Quintana Roo, 77506, Mexico More Info
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Local Institution - 0131
Puebla , 72424, Mexico More Info
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Local Institution - 0158
Lørenskog Kristiansand, 1478, Norway More Info
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Local Institution - 0163
Bodo , 8092, Norway More Info
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Local Institution - 0156
Kalnes , 1714, Norway More Info
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Local Institution - 0155
Oslo , 0379, Norway More Info
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Local Institution - 0171
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland More Info
Site 0171
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Local Institution - 0005
Opole Opolskie, 45-06, Poland More Info
Site 0005
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Local Institution - 0021
Krakow , 30-51, Poland More Info
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Local Institution - 0086
A Coruna A Coruña, 15006, Spain More Info
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Local Institution - 0012
Donostia Gipuzkoa, 20014, Spain More Info
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Local Institution - 0134
Badalona , 08916, Spain More Info
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Local Institution - 0047
Barcelona , 08035, Spain More Info
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Local Institution - 0024
Barcelona , 08036, Spain More Info
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Local Institution - 0153
Jaen , 23007, Spain More Info
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Local Institution - 0126
Madrid , 28009, Spain More Info
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Local Institution - 0056
Madrid , 28050, Spain More Info
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Local Institution - 0006
Sevilla , 41009, Spain More Info
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Local Institution - 0041
Valencia , 46009, Spain More Info
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Valencia , 46009, Spain More Info
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Local Institution - 0151
Valencia , 46014, Spain More Info
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Local Institution - 0062
Solna Stockholm, 171 6, Sweden More Info
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Local Institution - 0157
Linkoeping Vastergotland, 58185, Sweden
Local Institution - 0069
Uppsala , 751 8, Sweden
Local Institution - 0080
Chur , 7000, Switzerland More Info
Site 0080
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Local Institution - 0085
London Greater London, SE1 9, United Kingdom
Local Institution - 0120
Newcastle upon Tyne Northumberland, NE7 7, United Kingdom More Info
Site 0120
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Local Institution - 0087
Glasgow Strathclyde, G12 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

814

Study ID:

NCT05625399

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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